Microsoft Dynamics® AX medical device manufacturing solutions
With top-level Microsoft partnerships and certifications, and an unrivaled track record of success implementing Dynamics AX solutions for life sciences clients across all industry segments, RSM leverages its experiences as one of the largest Dynamics AX practices in the United States to help medical device manufacturers maximize their ERP investments.
The flexible, scalable, end-to-end solutions they provide are tailored to meet specific industry requirements and built on the proven Dynamics AX platform—all of which enable clients to gain visibility into large volumes of complex data, streamline operations across the enterprise, ensure compliance with applicable regulations and maximize critical operational efficiencies that improve their margins and profit.
Modern-day medical device manufacturing—insights into the industry
Valued at more than $140 billion in 2015, the U.S. medical device market—representing about 45 percent of the global market—is expanding at a brisk pace, with a projected compound annual growth rate of just over 6 percent for the period from 2014 to 2017. With growth driven partially by the enormous size of a now-aging baby boomer population, alongside increased incidences of chronic diseases, unprecedented levels of devices have been developed, manufactured and put into use. That said, balancing the value of such increasing demand against complex and often costly operational and regulatory requirements—from FDA regulations on device integrity to newly enforced device excise taxes—requires deep visibility into every segment of the supply chain, with the ability to track data and activity across every touch point to maximize productivity, control costs and enable seamless communications, data transfers and operations.
RSM understands pressures and business drivers for medical device manufacturers
With years of success working within segments of the life sciences industry, RSM’s Dynamics AX consultants are uniquely qualified to provide a deep level of support for medical device manufacturers—helping them pinpoint industry-specific concerns and opportunities—delivering Dynamics AX-based solutions that allow them to successfully address critical challenges, including requirements to:
- Alleviate pricing pressure: Offset pricing concerns—primarily those attributed to the 2.3 percent medical device excise tax regulation developed in 2013 under the Patient Protection and Affordable Care Act—by identifying opportunities to cut costs across the supply chain—all based on the increasing transparency and visibility required at every level of operations to reveal and correct for inefficiencies and resource-draining activities that threaten margin and profit.
- Improve enterprise-wide visibility: Achieve the real-time, supply chain-wide visibility necessary to drive more effective and accurate data management, allowing medical device manufacturers to quickly view quality and traceability device histories, component serialization information, subassemblies and final products—alongside inventory and production metrics—streamlining and optimizing operational speed responsiveness across departments.
- Maintain regulatory compliance: Comply with FDA requirements and standards for processing, safety and tracking across the medical device manufacturing value chain. Ensure compliance with these measures by capturing and maintaining accurate, centralized fully connected activity records at every level, helping to meet reporting requirements, better plan for audits and reduce the risk of heavy fines associated with noncompliance.
- Optimize production planning: Facilitate communication and collaboration as teams work together to drive each production stage forward, streamlining processes—from engineering change order (ECO) requests to product document management activities—to boost employee and operational productivity and effectiveness.
RSM’s technical consultants are industry veterans experienced in delivering solutions that allow medical device manufacturers to improve operational visibility and efficiencies while complying with the host of regulatory requirements the industry mandates—enabling them to better manage and control costs, boost profit and margins, and ultimately achieve sustainable growth and success.
Medical device manufacturers rely on tailor-made Dynamics AX functionality
The Dynamics AX platform enables functionality designed specifically to give medical device manufacturers capabilities they require to fully maximize operational efficiency, comply with regulatory mandates, and manage and control costs, with features that include:
Validation services: To comply with requirements from the FDA and other global regulatory agencies, medical device manufacturers must validate the implementation and intended use of their software systems (rather than the software itself)—when implementing or upgrading their software—to conduct system validation that is specific to a particular site and release. To support these requirements, RSM’s solutions for device manufacturers provide functional documentation, test protocols and scripts, a validation document portal, and other services and resources necessary for them to efficiently and effectively validate their instance of Microsoft Dynamics AX—all of which dramatically lowers both the costs and time associated with software qualification.
- Real-time status updates: Leveraging the benefits of a fully connected, enterprise-wide platform to capture and track manufacturing status and updates, device manufacturers are able to quickly and easily share production, inventory, quality and shipping data down to the shop floor.
- Product life-cycle traceability: Tracking devices as they travel through design and approvals to production and post-sale usage, device manufacturers are able to leverage robust version control capabilities to track the history of each design, enabling them to review and identify any discrepancies along the way to strengthen quality control. Forward and backward product traceability also provides a streamlined mechanism by which to access detailed records of each device’s life cycle, facilitating efficient and effective recall procedures.
- Production optimization and cost controls: Measuring device yields and profitability against labor costs while strategically scheduling production shifts and tracking the use of raw materials, device manufacturers are able to ensure resources are being leveraged optimally and in the most cost-effective manner possible.
- Improved inventory management: Quickly viewing inventory levels, device manufacturers are able to determine the availability of raw materials and active ingredients—often available and used in only small quantities—to reuse and recycle them as necessary to save vital resources. Inventory control also helps ensure product production is accurately mapped to customer demand, reducing the potential for shortages or overruns.
Members of RSM’s Dynamics AX consulting team are proven, trusted advisors with years of industry experience and successful implementations of Dynamics AX. This makes them uniquely qualified to deliver these and other critical elements of functionality to device manufacturing clients—helping them consolidate and optimize operations with a single, end-to-end solution to drive performance and profitability—all built on the flexible, scalable Dynamics AX platform.
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